Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers

Inclusion Criteria:

1. At least 18 years old.

2. Presence of a partial and full thickness DFU extending at least through the dermisand into the subcutaneous tissue down to the exposed tendon and fascia.

3. Wounds present anatomically on the foot as defined by beginning below the malleoliof the ankle, excluding wounds on the heel.

4. The index ulcer will be the largest ulcer if two or more eligible DFUs are presentand will be the only one evaluated in the study. If other ulcerations are present onthe same foot, they must be more than 2 cm distant from the index ulcer.

5. Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to first screening visit (SV1) and less than 1 year, as of the datethe subject consents for study.

6. Adequate circulation to the affected foot as documented by the following: palpablepedal pulses, pulses audibly biphasic or triphasic with handheld doppler, or recent (<6 month) vascular testing (both invasive & non-invasive).

7. Females of childbearing potential must be willing to use acceptable methods ofcontraception (birth control pills, barriers or abstinence) during the course of thestudy and undergo pregnancy tests.

8. Subject understands and is willing to participate in the clinical study and cancomply with weekly visits.

9. Subject understands they can exit the study at any time.

Exclusion Criteria:

1. Clinical signs of infection at the start of the study

2. Exposed bone(s)

3. Immunocompromised as determined by treating physician

4. Presence of greater than one full-thickness DFU less than 2 cm apart